Fluid delivery apparatus

ABSTRACT

A fluid container assembly which can be aseptically filled in the field with selected fluids and one which is specially designed for sterile coupling and use with fluid dispensing and delivery devices of the character that embody stored energy sources such as compressible cellular masses and distendible elastomeric membranes that form, in conjunction with a cooperating base, fluid chambers for containing the fluid to be dispensed.

BACKGROUND OF THE INVENTION

This is a Divisional application of application, Ser. No. 08/269,445,filed Jun. 30, 1994 now U.S. Pat. No. 5,569,236 which is a ContinuationIn Part Application of application, filed Sep. 29, 1993, Ser. No.08/129,470 which has now issued into U.S. Pat. No. 5,374,256, which is aContinuation In Part of application, Ser. No. 08/129,693, filed Sep. 29,1993 which has now issued into U.S. Pat. No. 5,419,771, which is aContinuation In Part of Ser. No. 08/069,937 filed May 28, 1993 which hasnow issued into U.S. Pat. No. 5,336,188, which is a Continuation In Partof Ser. No. 08/046,438, filed May 18, 1993 which has now issued intoU.S. Pat. No. 5,411,480, which is a Continuation In Part of applicationSer. No. 07/987,021 filed Dec. 7, 1992 which has now issued into U.S.Pat. No. 5,279,558, which is a Continuation of application Ser. No.07/870,269, filed Apr. 17, 1992 which has now issued into U.S. Pat. No.5,205,820 and which is, in turn, a Continuation In Part of applicationSer. No. 07/642,208, filed Jan. 16, 1991 which has now issued to U.S.Pat. No. 5,169,389 which is a Continuation In Part of application Ser.No. 07/367,304 Filed Jun. 16, 1989 which has now issued to U.S. Pat. No.5,019,047.

FIELD OF THE INVENTION

The present invention relates generally to fluid delivery devices. Moreparticularly, the invention concerns an improved apparatus for infusingmedicinal agents into an ambulatory patient at specific rates overextended periods of time and to a novel fluid containing vial assemblywhich can be field filled and then used to charge the fluid reservoirsof the fluid delivery apparatus.

DISCUSSION OF THE INVENTION

Many medicinal agents require an intravenous route for administrationthus bypassing the digestive system and precluding degradation by thecatalytic enzymes in the digestive tract and the liver. The use of morepotent medications at elevated concentrations has also increased theneed for accuracy in controlling the delivery of such drugs. Thedelivery device, while not an active pharmacologic agent, may enhancethe activity of the drug by mediating its therapeutic effectiveness.Certain classes of new pharmacologic agents possess a very narrow rangeof therapeutic effectiveness, for instance, too small a dose results inno effect, while too great a dose results in toxic reaction.

In the past, prolonged infusion of fluids has generally beenaccomplished using gravity flow methods, which typically involve the useof intravenous administration sets and the familiar bottle suspendedabove the patient. Such methods are cumbersome, imprecise and requirebed confinement of the patient. Periodic monitoring of the apparatus bythe nurse or doctor is required to detect malfunctions of the infusionapparatus.

Devices from which liquid is expelled from a relatively thick-walledbladder by internal stresses within the distended bladder are well-knownin the prior art. Such bladder, or "balloon" type, devices are describedin U.S. Pat. No. 3,469,578, issued to Bierman and in U.S. Pat. No.4,318,400, issued to Perry. The devices of the aforementioned patentsalso disclose the use of fluid flow restrictors external of the bladderfor regulating the rate of fluid flow from the bladder.

The prior art bladder type infusion devices are not without drawbacks.Generally, because of the very nature of bladder or "balloon"configuration, the devices are unwieldy and are difficult and expensiveto manufacture and use. Further, the devices are somewhat unreliable andtheir fluid discharge rates are frequently imprecise.

The apparatus of the present invention overcomes many of the drawbacksof the prior art by eliminating the bladder and making use of recentlydeveloped elastomeric films, expandable foams and similar materials,which, in cooperation with a base defines a fluid chamber that containsthe fluid which is to be dispensed. The elastomeric film membrane or theexpandable foam member controllably forces fluid within the chamber intofluid flow channels provided in the base.

The elastomeric film materials used in the apparatus of the presentinvention, as well as various alternate constructions of the apparatus,are described in detail in U.S. Pat. No. 5,205,820 issued to the presentinventor. Therefore, U.S. Pat. No. 5,205,820 is hereby incorporated byreference in its entirety as though fully set forth herein. Co-pendingU.S. Ser. No. 08/046,438 filed by the present inventor on Apr. 13, 1993also describes various types of expandable cellular elastomers andelastomeric foams used in making the expandable member of variousphysical embodiments of the invention. This application is also herebyincorporated by reference in its entirety as though fully set forthherein.

The apparatus of the invention can be used with minimal professionalassistance in an alternate health care environment, such as the home. Byway of example, devices of the invention can be comfortably andconveniently removably affixed to the patient's body and can be used forthe continuous infusion of antibiotics, hormones, steroids, bloodclotting agents, analgesics, and like medicinal agents. Similarly, thedevices can be used for I-V chemotherapy and can accurately deliverfluids to the patient in precisely the correct quantities and atextended microfusion rates over time.

One of the devices described in Continuation-In-Part application, Ser.No. 08/069,937 and illustrated in FIGS. 34 and 35 thereof includesfirst, second, and third cooperating fluid chambers which can beselectively filled by individual fluid containers or vials containingvarious fluids such as diluents and medicaments. The novel apparatusshown in FIGS. 34 and 35 permits two or more liquid components to bestored within the reservoirs of the apparatus and then controllablyintermixed at the time of fluid delivery. In U.S. application Ser. No.08/129,693, there is described a number of inventions which expand oninventions described in the Ser. No. 08/069,937 application by providinga novel platform support system to which several fluid dispensers ofvarying volume can be operably interconnected. Both this last mentionedapplication, Ser. No. 08/129,693, as well as Ser. No. 08/069,937 areincorporated herein by reference as though fully set forth herein.

The present application expands further on the concepts disclosed in theapplications identified in the preceding paragraph by providing a novelfluid container or vial that is usable with the apparatus of theseinventions and is of a unique design which permits it to beexpeditiously filled in the field.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide an apparatus forexpelling fluids at a precisely controlled rate which is of a compact,low profile, laminate construction. More specifically, it is an objectof the invention to provide such an apparatus which can be used for theprecise infusion of pharmaceutical fluids to an ambulatory patient atcontrolled rates over extended periods of time.

It is a particular object of the invention to provide a device of theaforementioned character which embodies stored energy sources such asdistendable elastomeric membranes, that form in conjunction with acooperating base, fluid chambers for containing the fluids to bedispensed. The novel aseptically field fillable vial assembly of thepresent invention is specially designed for use with these types ofdevices so that they can be expeditiously filled in the field shortlybefore use with a wide variety of medicinal fluids.

By way of summary description, the novel vial construction of thepresent invention permits field filling of either individual fluiddispensers of the character described in the preceding paragraphs, oralternatively, permits the field filling of multireservoir devices whichallow for the controlled delivery therefrom of large volumes of the sameor different fluids at controlled rates in accordance with apredetermined delivery protocol.

In one form of the fluid container of the present invention, the fluidchamber thereof can also be quickly and easily filled in the field usinga conventional hypodermic syringe. After filling, the vial assembly canbe coupled with the delivery system in a manner to insure the aseptictransfer of the fluid to be delivered.

Another object of the invention is to provide field fillable vialassemblies of the class described which can be filled and then storedunder refrigeration for an extended period. For those types ofassemblies, a novel temperature indicator is provided as an integralpart of the assembly.

Another object of the invention is to provide field fillable vialassemblies which can be expeditiously filled by automated filingmachines located either in the hospital pharmacy or by the homehealth-care pharmacist.

Other objects of the invention are set forth in U.S. Pat. No. 5,205,820and Ser. No. 08/069,937 which are incorporated herein and will becomemore apparent from the discussion which follows.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a generally perspective, exploded view of one form of thefield filled vial assembly of the present invention showing it beingfilled by means of a conventional hypodermic syringe.

FIG. 2 is an exploded, generally perspective view of one form of thefluid container or vial assembly of the invention.

FIG. 3 is an enlarged, fragmentary, cross-sectional side view of thevial assembly showing the cap removed and the internal plunger thereofbeing pierced by the syringe needle.

FIG. 4 is a fragmentary, perspective view of one form of the fluiddispenser with which the vial assembly of the present invention can beused.

FIG. 5 is a generally perspective, exploded view of an alternate form ofthe field filled vial assembly of the present invention.

FIG. 5A is a fragmentary, generally perspective view of a check valveassembly of the assembly shown in FIG. 5.

FIG. 6 is a fragmentary, generally perspective view of the fill endportion of the assembly shown in FIG. 5.

FIG. 7 is a generally perspective illustrating view showing the assemblyof FIG. 5 being filled by a conventional syringe having a luer typeconnector.

FIG. 8 is an enlarged, foreshortened, cross-sectional side view of thevial assembly of FIG. 5.

FIG. 8A is an enlarged cross-sectional view taken along lines 8A--8A ofFIG. 8.

FIG. 9 is a fragmentary, cross-sectional, exploded view of the fill endportion of the assembly showing the removal of the end cap and theinterconnection of a syringe with the fill end portion.

FIG. 10 is a generally perspective, exploded view of yet another form ofthe field filled vial assembly of the present invention.

FIG. 10A is a fragmentary, generally perspective view of a check valveassembly of the assembly shown in FIG. 10.

FIG. 11 is an enlarged, foreshortened, cross-sectional side view of thevial assembly of FIG. 10.

FIG. 11A is an enlarged cross-sectional view taken along lines 11A--11Aof FIG. 11.

FIG. 12 is a cross-sectional view taken along lines 12--12 of FIG. 11.

FIG. 13 is a cross-sectional view taken along lines 13--13 of FIG. 11.

FIG. 14 is a fragmentary, cross-sectional exploded view of the fill endportion of the assembly showing the removal of the end cap and theinterconnection of a syringe with the fill end portion.

FIG. 15 is a generally perspective, exploded view of another form of thefield filled vial assembly of the present invention which is adapted tobe filled by a blunt cannula.

FIG. 16 is a fragmentary, generally perspective view of one end portionof the vial assembly shown in FIG. 15.

FIG. 17 is an enlarged, cross-sectional side view of the vial assemblyshown in FIG. 15.

FIG. 18 is an enlarged cross-sectional view of the device of theinvention shown in FIG. 17 with the cap having been removed and thefluid chamber having been filled with a syringe provided with a bluntcannula.

FIG. 19 is a cross-sectional view similar to FIG. 18, but showing thevial assembly mated with a fluid dispenser also having a blunt cannula.

FIG. 20 is a generally perspective, exploded view of another form of thefield filled vial assembly of the present invention adjusted to befilled by means of a blunt cannula.

FIG. 21 is an enlarged, cross-sectional side view of the vial assemblyshown in FIG. 20.

FIG. 22 is an enlarged cross-sectional view of the device of theinvention shown in FIG. 21 with the cap having been removed and thefluid chamber being filled with a syringe provided with a blunt cannula.

FIG. 23 is a cross-sectional view similar to FIG. 22 but showing thevial assembly mated with a fluid dispenser having a valve operatingmember for opening the fluid outlet valve of this last form of theinvention.

FIG. 24 is a cross-sectional view taken along lines 24--24 of FIG. 23.

FIG. 25 is a fragmentary, generally perspective view of the fluid outletvalve of the vial assembly and the valve operating means of the fluiddispenser.

FIG. 26 is a generally perspective, exploded view of still another formof the field filled vial assembly of the present invention which isadapted to be filled by means of a slip-fit luer connector.

FIG. 27 is a fragmentary, generally perspective view of the fill endportion of the vial assembly shown in FIG. 26.

FIG. 28 is an enlarged, cross-sectional side view of the vial assemblyshown in FIG. 26.

FIG. 29 is an enlarged, cross-sectional view of the device of theinvention shown in FIG. 28 with the cap having been removed and thefluid chamber having been filled with a syringe provided with a slip-fitluer connector.

FIG. 30 is a cross-sectional view similar to FIG. 29, but showing thevial assembly mated with a fluid dispenser having means for opening theduck-bill type fluid outlet valve of this last form of the invention.

FIG. 31 is a generally perspective view of the duckbill type fluidoutlet valve.

FIG. 32 is a side elevational view of another form of vial assemblyspecially designed for use with cardet type dispensers of the characterdescribed in U.S. Ser. No. 08/129,693 and generally shown in FIG. 23 ofthe application.

FIG. 33 is a side elevational view, which is partly broken away to showninternal construction, showing the vial assembly mated with a typicalcardet type dispenser unit.

FIG. 34 is a fragmentary, generally perspective, exploded view of thefluid outlet portion of the vial assembly shown in FIG. 32.

FIG. 35 is an enlarged, cross-sectional side view of the vial assemblyshown in FIG. 32.

FIG. 36 is an enlarged cross-sectional view of the device of theinvention shown in FIG. 35 with the cap having been removed and thefluid chamber having been filled with a syringe provided with a slip-fitluer connector.

FIG. 37 is a cross-sectional view similar to FIG. 36, but showing thevial assembly mated with a fluid dispenser of the character usable withcardet type platform supports.

FIG. 38 is an enlarged, cross-sectional view of part of the left portionof FIG. 37, showing greater detail of construction.

FIG. 39 is a cross-sectional view taken along lines 39--39 of FIG. 38.

FIG. 40 is an enlarged, generally perspective view of the fluid outletvalve operating member of the fluid dispenser of FIG. 37.

FIG. 41 is a generally perspective, exploded view of yet another form ofthe field filled vial assembly of the present invention which is adaptedto be filled by means of a syringe provided with a conventional luerconnector.

FIG. 42 is an enlarged, cross-sectional side view of the vial assemblyshown in FIG. 41.

FIG. 43 is an enlarged, cross-sectional view of the device of theinvention shown in FIG. 42 with the cap having been removed and thefluid chamber being filled with a syringe provided with a conventionalluer connector.

FIG. 44 is a generally perspective view of the fill end portion of thevial assembly shown in FIG. 43.

FIG. 45 is a cross-sectional view similar to FIG. 43 but showing thevial assembly mated with a fluid dispenser also having an outlet valveoperating member.

FIG. 46 is an enlarged, cross-sectional view of part of the left portionof FIG. 45 showing greater detail of construction.

FIG. 47 is a generally perspective fragmentary view of the fluid outletvalve operating member of the fluid dispenser.

FIG. 48 is a cross-sectional side view of another form of vial assemblyof the present invention.

FIG. 49 is an enlarged, cross-sectional view of the device of theinvention shown in FIG. 48 with the cap having been removed and thefluid chamber having been filled with a syringe provided with a slip-fitconnector.

FIG. 50 is a cross-sectional view similar to FIG. 49 but showing thevial assembly mated with a fluid dispenser also having a fluid outletvalve operating member of unique construction.

FIG. 51 is an enlarged, cross-sectional view of part of the left portionof FIG. 50 showing additional detail of construction.

FIG. 52 is a generally perspective fragmentary view of the fluid outletvalve operating member.

FIG. 53 is a generally perspective, exploded view of still another formof the field filled vial assembly of the present invention which isadapted to be filled by means of a conventional luer type syringe.

FIG. 54 is an enlarged, cross-sectional side view of the vial assemblyshown in FIG. 53.

FIG. 55 is an enlarged, cross-sectional view of the device of theinvention shown in FIG. 54 with the cap having been removed and thefluid chamber having been filled with the syringe.

FIG. 56 is a cross-sectional view similar to FIG. 55, but showing thevial assembly mated with a fluid dispenser having a valve operatingmember.

FIG. 57 is an enlarged, cross-sectional view of a part of the leftportion of FIG. 56 showing additional detail of construction.

FIG. 58 is a generally perspective fragmentary view of the fluid outletvalve operating member of the dispenser of this latest form of theinvention.

DESCRIPTION OF THE INVENTION

Referring to the drawings and particularly to FIGS. 1 through 3, oneform of the vial assembly of the invention is there illustrated andgenerally identified by the numeral 12. The apparatus comprises atransparent container, or vial, 14 having a fluid chamber 14a forcontaining the fluid to be added to the reservoir of a fluid dispenseror other fluid delivery device. The fluid can be a diluent or any of themedicaments or beneficial agents described in the previously identifiedU.S. Pat. No. 5,205,820. Vial 14 has open ends 14b and 14c and closelyreceives a pierceable piston-like plunger 16 which is movable withinvial 14 from a first position, shown in FIG. 3, where it is proximateend 14b of the vial to a second position where it is disposed proximateend 14c of the vial. Container 14 can be a glass vial or any othersuitable sterile container for containing the fluid that is to be usedin filling the reservoirs of the fluid dispensers or fluid deliverydevices.

Also forming a part of the vial assembly of the present embodiment ofthe invention is an outer safety casing 18, shown here as comprisingcooperating first and second portions 18a and 18b which are joined toform a sterile barrier system. First portion 18a is provided withthreads 20 and is closed by a threaded closure cap 22. Provided at itsopen end is a socket like construction 24 which is telescopicallyreceived within the open end portion 26 of second casing portion 18b.Outer casing 18 is receivable over vial 14 and portions 18a and 18b areheld in mating engagement by an overwrap 30 which functions as aninterface sterility barrier and upon which appropriate identifyingindicia 32 can be imprinted. A novel temperature indicator means, suchas indicator "T", is also carried by overwrap 30. Indicator "T" may be areversible liquid crystal temperature bar indicator of a character whichis readily commercially available from sources such as Clark Researchand Development of Chicago, Ill., Thermax of Anaheim, Calif. andAmerican Thermo Instruments of Dayton, Ohio. Indicator "T" providesinformation as to the approximate temperature of the vial assemblyduring storage and at time of use.

As shown in FIG. 2, a guide bead 32 is provided on portion 24. Bead 32is receivable within a corresponding channel 33 provided in portion 18bto insure that portions 18a and 18b of the outer casing are properlyaligned.

In a manner presently to be described, as the fluid chamber of the vialis filled with fluid using syringe "S" (FIG. 1), penetrable piston 16 ismoved within the vial from the first position shown in FIG. 3 to asecond position wherein it is disposed proximate end 14c. Piston 16 isprovided with a plurality of circumferentially extending sealing beads16a which sealably engage the inner walls 14d of container 14 as thepiston moves rearwardly thereof so as to prevent fluid leakage past thepiston.

Referring now to FIG. 3, after the vial assembly has been assembled inthe manner shown in FIG. 1 and with cap 22 removed, a tear away closurecover 37 is removed. Next the needle "N" of the syringe "S" is used topenetrate a pierceable means shown here as an elastomeric plug 38 whichcloses end 14b of vial 14. As shown in FIG. 3, plug 38 is held inposition within vial 14 by an aluminum crimp cap 40, the periphery ofwhich is crimped over into a circumferential groove 42 providedproximate end 14b of the vial. As fluid is forced from the syringe intoan interior chamber 16b of plunger 16, the plunger will be forced to theleft until it moves into close proximity with end 14c of the vial whereit engages a retainer ring 44 (FIG. 2) that is closely received withinend 14c of the vial. During the vial filling step, air disposed withinchamber 14a will be expelled through a sterile vent patch 45 which isbonded to a closure cap 46 that is provided with vent apertures 46a.

After the vial has been filled with the selected fluid, cap 22 isreconnected with the outer casing 18 so as to maintain the interior ofthe vial in a sealed, aseptic condition. As best seen in FIG. 2, casing18 is provided with an elongated viewing slot 50 that permits viewing ofthe interior chamber 14a of the vial. Similarly, overwrap 30 has anelongated viewing slot 52 which is indexable with slot 50. With thisconstruction, the user can tell at a glance whether the vial is full orempty.

In its sealed, aseptic condition with a sterile fluid path, vialassembly 12 can be stored as may be necessary until it is to be used tofill a fluid dispenser or a reservoir of a delivery apparatus such asthat shown in FIGS. 34 and 35 of U.S. Ser. No. 08/069,937

Turning now to FIG. 4, the vial assembly is there shown being used tofill the fluid chamber of a fluid dispenser of the character having abase 56, a stored energy means for forming, in conjunction with thebase, a fluid chamber and a cover means which is receivable over thebase for sealably enclosing the stored energy means. The stored energymeans is here shown as comprising a distendable membrane 58, of thegeneral character described in U.S. Pat. No. 5,205,820 at Column 9,Lines 3-59. The cover means (not shown) comprises a cover 34 of thegeneral character shown in FIG. 61 of U.S. Pat. No. 5,205,820. Referenceshould be had to these patents for a full understanding of theconstruction and operation of the fluid dispenser shown in FIG. 4.

After tear-away cover 46 has been removed from the vial assembly (FIG.2), the outboard end 60 of the vial assembly, which presents a sterileinterface, is inserted into the likewise sterile inlet opening 62 of thedispenser unit to accomplish a sterile coupling. As indicated in FIG. 4,the dispenser unit is provided with first flow means for establishingsterile fluid communication between the fluid inlet 66 of the reservoirsof the fluid dispenser and chamber 14a of vial 14, when the fillingassemblage is mated with the fluid dispenser. In the embodiment of theinvention, shown in FIG. 4, the first flow means comprises a piercingcannula assembly 68 which includes an outwardly protruding hollowcannula 70. The cannula assembly 68 also includes a housing 72 whichsupports hollow needle 70. Housing 72 is connected to the outboard end84a of an elongated stem 84 which is provided with a central fluidpassageway 86 that communicates with the reservoirs of the fluiddispenser.

After end 60 of the vial assembly is inserted into inlet port 62 of thefluid dispenser, an inward pressure exerted against the vial assemblywill cause hollow cannula 70 to penetrate penetrable elastic septal plug38 piston 16 of the vial assembly opening a fluid flow passagewaybetween passageway 86 of the fluid dispenser and chamber 14a of the vialassembly. As shown in FIG. 4, casing 18b of the vial subassembly isprovided with a multiplicity of outwardly extending, resilientlydeformable locking elements 88, which comprise a part of theinterlocking means of the invention for interlocking together the vialassembly and the fluid dispenser. Elements 88 are adapted to slide pasta multiplicity of inwardly extending teeth 90 provided within inlet 62of the fluid dispenser. These teeth are so constructed and arranged asto engage elements 88 in a manner to permit insertion of the vialassembly into the dispenser inlet but to prevent its removal after ithas been fully telescopically inserted into the inlet of the fluiddispenser. To insure proper alignment between the filling subassemblyand the inlet of the fluid dispenser, forward and rearward guide rails92 and 94 are closely receivable within longitudinally extending tracks96 provided within the inlet of the fluid dispenser.

As previously mentioned, indicator means are provided for indicating thevolume of fluid remaining within vial 14 as the vial assembly isinserted into the inlet of the fluid dispenser. This indicator meanscomprises the previously identified viewing slots 50 and 52 along whichare disposed a multiplicity of indicating indicia 97 (FIG. 2). Sincevial 14 is transparent, the amount of fluid remaining within the vial atany point in time can readily be determined by merely aligning one ofthe indicia markings on the casing with the inboard extremity of piston16 as it moves toward its innermost position.

As previously mentioned, the vial assemblies of the present inventioncan also be conveniently coupled with connector means 414a, 414b and414c of the multireservoir devices illustrated in FIGS. 34 and 35 ofU.S. Ser. No. 08/069,937 and can be used to fill the reservoirs of thesedevices in the manner described in this co-pending application. As astudy of this earlier application will make clear, the manner ofcoupling of the vial assemblies herein described with the devicesdisclosed in U.S. Ser. No. 08/069,937.

Referring to FIGS. 5 through 9, an alternate form of vial assembly ofthe present invention is there illustrated and generally identified bythe numeral 102. The apparatus of this embodiment of the invention issimilar in many respects to that shown in FIGS. 1 and 2 and includes avial 104 having a fluid chamber 104a for containing the fluid to beadded to the reservoir of a fluid dispenser or other fluid deliverydevice. As before the fluid can be a diluent or any of the medicamentsor beneficial agents described in the previously identified U.S. Pat.No. 5,205,820.

The major difference between the vial assembly of this form of theinvention and that shown in FIGS. 1 and 2 is that this latter form ofthe invention is specifically designed for use with needleless syringeshave luer type connectors. Such syringes have recently become verypopular due to needle-stick problems experienced in using traditionalneedle type syringes.

As best seen in FIG. 5, vial 104 has open ends 104b and 104c and closelyreceives within chamber 104a a piston-like plunger 106 which istelescopically movable within chamber 104a from a first position,proximate the fill end 104b of the vial to a second position proximateopposite end 104c of the vial (see FIG. 9). Container 104 can be a glassvial, or a plastic vial, or any other suitable container that can besterilized. Container 104 has an interior wall, the interior surface ofwhich can be covered by covering means such as interfacial barriermaterials or which can remain uncoated depending upon the base materialused in constructing the container and depending upon the application tobe made of the device. Containers of the type contemplated herein can beeffectively used for very long-term storage. As shown in FIGS. 8 and 8A,the interior of the vial assembly of the embodiment of the inventionthere shown is covered by a thin laminate coating 105 which herecomprises first, second and third layers 105a, 105b, and 105c. Theselayers cooperate to form a tailored barrier structure which alters thesurface morphology of the vial and which can control the diffusiontransport of water, water vapor and various gases. The materials used toform the layers can selectively comprise both rubber and glassy advancedpolymers, including thermoplastic films such as polyvinylchloride (PVC),copolymers of vinylidene chloride and vinylchloride, polyethyleneterephthalate (PET), tetrafluoroethylene-hexafluoropropylene andvinylidene flouride (THV fluroplastic) ethylene, viny alcoholcopolymers, advance polyesters, such as polyethylene napthalenedicarboxylate, advance amorphous polymers, including polyvinyl chlorideand polystyrene. Various oxygen barrier resins can also be used,including vinylidene chloride, aromatic nylon, amorphous nylon,polyacrylicimide and similar resins offered for sale by The Dow ChemicalCompany, Rohm & Hass and DuPont.

Surface coatings of the character here contemplated can include singleor multiple layers of similar or different materials. The interfacialcoating or coatings can be employed to increase the functional surfacecompatibility of the vial base material with the intended vial contents,the barrier properties of the vial base materials, including its gaspermeation, migration and perm select characteristics and for optimizingthe morphology of the internal vial material for specific applications.

Materials suitable for the construction of plastic vials includepolycarbonate, high density polyethylene, polypropylene, nylon,polystyrene, polyamides, styrenes, and various like materials.

Also forming a part of the vial assembly of the present embodiment ofthe invention is an outer safety casing, shown here as comprisingcooperating first and second portions 108a and 108b which are joinedtogether to form a sterile barrier system. First portion 108a isprovided with internal threads 110 and is closed by an externallythreaded closure cap 112. Provided at its open end is a socket likeconstruction 114 which is telescopically received within the open endportion 116 of second casing portion 108b. The outer casing isreceivable over vial 104 and portions 108a and 108b are held in matingengagement by an over-wrap 120 which functions as an interface sterilitybarrier and upon which appropriate identifying indicia 122 can beimprinted. A novel temperature indicator means, such as indicator "T",of the character previously described is also carried by overwrap 120.As shown in FIG. 5, a guide bead 124 is provided on portion 114. Bead124 is receivable within a corresponding channel 126 provided in portion108b to insure that portions 108a and 108b of the outer casing areproperly aligned.

In a manner presently to be described, as the fluid chamber of the vialis filled with fluid using a needleless syringe "NS" (FIG. 7), piston106 is moved within the vial by fluid pressure from the first positionshown in FIG. 9 to a second position shown in FIG. 8 where it isdisposed proximate end 104c. Piston 106 is provided with a plurality ofcircumferentially extending sealing beads 106a which sealably engage theinner walls 104d of container 104 as the piston moves internally thereofso as to prevent fluid leakage past the piston.

Referring now to FIGS. 6 and 8, after the vial assembly has beenassembled in the manner shown in FIG. 8 and with cap 112 removed, theconnector stem portion 130 of the syringe connector means is exposed toview (see FIG. 6). The syringe connector means of this form of theinvention functions to inter-connect the container with a needlelesssyringe of the character having a luer type receptacle adapted toreceive a luer type connector "L" of the character provided at theterminal portion of the connector stem 130. The syringe connector meansalso comprises sealing means for sealing the inlet portion of vial 104.In the present form of the invention, the sealing means, in addition toconnector stem 130, also includes inlet valve means for controllingfluid flow into chamber 104a. The inlet valve means here comprises adelivery stem 132 which terminates in a valve seat 134 (FIG. 5A).Disposed intermediate connector stem 130 and delivery stem 132, andintegrally formed therewith, is a disk-like body portion 136 (FIG. 8).The various components of inlet valve means can be constructed ofvarious dimensionally stable bondable materials, such as polycarbonate,polystyrene, nylon and various acrylic polymers.

As best seen by referring to FIG. 8, connector stem 130 has a centralfluid passageway 130a while delivery stem 132 has a central fluidpassageway 132a. The inlet valve means, in addition to valve seat 134,comprises a valve member 140 which is movable into sealable engagementwith valve seat 134 in the manner shown in FIG. 8 so as to substantiallyblock fluid flow through fluid passageway 132a. The inlet valve means ofthe present form of the invention also includes a valve housing 142disposed adjacent delivery stem 132 for housing valve member 140 and forpermitting movement of the valve member between the first substantiallysealing position shown in FIG. 8 toward a second valve open positionshown in FIG. 9. Valve housing 142 includes a cylindrical body portion142a and a flange portion 142b. Cylindrical body portion 142a, which isadapted to telescopically receive delivery stem 132, is also providedwith a fluid passageway 142c. With this construction, when the valvemeans of the invention is in the open position shown in FIG. 9, fluidcan flow through the connector means, past the valve member 140, throughpassageway 142c, and into the interior chamber 104a of container 104.When chamber 104a is filled, fluid pressure within the chamber willcause the valve to return to a closed position.

The sealing means of the invention which functions to close first end104b of container 104, further includes an elastomeric plug-like member146 having a central bore 146a, a generally cylindrically shaped bodyportion 146b, and an enlarged diameter flange portion 146c (FIGS. 5 and8). Suitable materials for member 146 include silicone rubber, butylrubber, butylpolyisoprene blend, ethylene-propylene elastomers, or anyother elastomeric material compatible with the vial contents. As shownin FIG. 8, cylindrical portion 146b fits snugly within vial 104 and incooperation with connector stem 130, valve housing 142, and valve member140, functions to sealably close end 104b of container 104. To maintainthe aforementioned components in position within container 104,interconnection means are provided which here take the form of a crimpcap 150 having a skirt portion 150a, the periphery 150b of which can becrimped inwardly into an annular groove 152 which is provided incontainer 104 (FIG. 8). Crimp cap 150 can be constructed from a varietyof malleable materials including aluminum, stainless steel and likematerials. Disposed between flange 150c of the crimp cap and bodyportion 136 of the connector means is an elastomeric annular-shapedcrimp seal 154. In engagement with the opposing face of the flange 150is an interior partition wall 158 formed in portion 108a of the outersafety casing. When closure cap 112 is threadably connected with portion108a in the manner shown in FIG. 8, the inner edge of the cap is inclose proximity with wall 158 and a centrally disposed cylindricalextension 160 formed on cap 112 is telescopically received withinpassageway 130a of connector stem 130.

In filling the vial assembly, cap 112 is removed and syringe "NS" isinterconnected with the connector stem 130 in the manner shown in FIGS.7 and 9 so that luer connector "L" is securely locked within the syringereceptacle. As fluid is forced from the syringe into passageways 130aand 132a, valve member 140 will be moved away from seat 134 and fluidwill flow toward chamber 104a of the container and will impinge onplunger 106. The fluid impinging on the plunger 106, will force it tothe left until it moves into close proximity with end 104c of the vialwhere it engages a retainer ring 162 (FIG. 9) that is closely receivedwithin end 104c of the vial. During the vial filling step, air disposedwithin chamber 104c will be expelled through a sterile vent patch 164which is bonded to a closure cap 166 that is provided with ventapertures 166a. Vent patch 164 can be constructed from a gas permeablehydrophobic material such as expanded polytetrafluoroethylene (PTFE)membrane or an acrylic copolymer membrane on a nonwoven support.

After the vial has been filled with the selected fluid, cap 112 isreconnected with the outer casing 108 so as to maintain the interior ofthe vial in a sealed, aseptic and sterile condition. As best seen inFIG. 5, casing portions 108a and 108b is provided with an elongatedviewing slot 170 that permits viewing of the interior chamber 104a ofthe vial. Similarly, overwrap 120 has an elongated viewing slot 172which is indexable with slot 170. With this construction, the user cantell at a glance whether the vial is full, partially full, or empty.

In its sealed, aseptic condition with a sterile fluid path, vialassembly 102 can be stored as may be necessary until it is to be used tofill a reservoir of a fluid dispenser of a delivery apparatus such asthat shown in FIGS. 34 and 35 of U.S. Ser. No. 08/069,937.

Turning now to FIGS. 10 through 14, still another form of the vialassembly of the present invention is there shown. This embodiment issimilar in many respects to that shown in FIGS. 5 through 9 save thatthe vial or fluid chamber is constructed of plastic and is non-circularin cross section. Like numerals have been used in FIGS. 10 through 14 toidentify like components.

As best seen in FIGS. 10 and 11, the apparatus of this latest form ofthe invention comprises a fluid container 180 having end portions 180aand 180b and closely receives within a chamber 180c a piston-likeplunger 182 which is telescopically movable within chamber 180c from afirst position, proximate the fill end 180a of the container to a secondposition proximate opposite end 180b of the container (see FIG. 11). Aspreviously mentioned, container 180 is formed of plastic and, as shownin FIG. 12, is generally elliptical in cross section. The interiorsurface of the container can be coated or uncoated depending upon thematerial used in constructing the container and depending upon the useto be made of the device. As shown in FIGS. 11, 11A and 12, the interiorof the container of the embodiment of the invention there shown iscovered with a thin laminate interfacial structure 185 made up of layers185a, 185b, and 185c. These layers are of the general character oflayers 105 as previously described in connection with the embodiment ofthe invention shown in FIGS. 7 and 8 and can be formed of materials ofthe type previously identified herein. It is to be understood that forsome applications, only a single layer coating, such as a plasmadeposited facing surface, having vapor barrier properties, can be used.

Also forming a part of the vial assembly of this latest embodiment ofthe invention is an overwrap 188 which surrounds container 180 andfunctions as a medicament instruction label upon which appropriateidentifying indicia 190 can be imprinted. As before, a novel temperatureindicator means, such as indicator "T", of the character previouslydescribed is also carried by overwrap 188.

As was the case with the embodiment of the invention shown in FIGS. 5through 10, the fluid chamber of the container is filled with fluidusing a needleless syringe "NS" (FIG. 14). As the chamber is filled,piston 182 is moved within the vial by fluid pressure from the firstposition shown in phantom lines in FIG. 11 to a second position shown bythe solid lines in FIG. 11 where it is disposed proximate end 180b.Piston 182, which is generally elliptical in cross section, is providedwith a plurality of circumferentially extending sealing beads 182a whichsealably engage the inner walls 180d of container 180 as the pistonmoves internally thereof so as to prevent fluid leakage past the piston.

Referring particularly to FIGS. 11 and 14, an internally threaded capadapter 194 is affixed to end 180a of container 180 by any suitablemeans such as sonic bonding. Adapter 194 is generally circular in crosssection at any point and functions to receive an externally threadedclosure cap 196.

Mounted within adapter 194 is the sealing means of this form of theinvention, which is substantially identical to that previously describedand functions to seal the inlet of the vial chamber and also functionsto interconnect the container with a needleless syringe of the typehaving a luer type receptacle. As before, the connector stem 130 isprovided with a luer type connector "L" which is lockably receivedwithin the syringe receptacle in the manner shown in FIG. 14. Theconnector means, in addition to connector stem 130, also comprises adelivery stem 132 which terminates in a valve seat 134. Disposedintermediate connector stem 130 and delivery stem 132, and integrallyformed therewith, is a disk-like body portion 136.

As best seen by referring to FIGS. 10 and 11, connector stem 130 has acentral fluid passageway 130a while delivery stem 132 has a centralfluid passageway 132a. The sealing means also includes inlet valve meansfor controlling fluid flow into the vial chamber. This valve means isalso similar to the previously described valve means and comprises avalve member 140 which is movable into sealable engagement with valveseat 134 in the manner shown in FIG. 11 so as to block fluid flowthrough fluid passageway 132a. The valve means of this latest form ofthe invention also includes a valve housing 142 disposed adjacentdelivery stem 132 for housing valve member 140 and for permittingmovement of the valve member between the first sealing position shown inFIG. 11 toward a second valve open position shown in FIG. 10A. Valvehousing 142 includes a cylindrical body portion 142a and a flangeportion 142b. Cylindrical body portion 142a, which is adapted totelescopically receive delivery stem 132, is also provided with a fluidpassageway 142c. With this construction, when the valve means of theinvention is in the open position, fluid can flow through the connectormeans, past the valve member 140, through passageway 142c, and into theinterior chamber 180c of container 180. When the chamber is filled,fluid pressure within the chamber will cause the valve to return to itsclosed position.

To close first end 180a of container 180, closure cap 196 is threadablyconnected to an annular threaded portion or cap adapter 194 in themanner shown in FIG. 11.

In filling container 180, cap 196 is removed in the manner shown in FIG.14 and syringe "NS" is interconnected with the connector stem 130 sothat luer connector "L" is securely locked within the syringereceptacle. As fluid is forced from the syringe into passageways 130aand 132a, elastomeric valve member 140 will be moved away from seat 134and fluid will flow toward chamber 180c of the container and willimpinge on plunger 182. The fluid impinging on the plunger 182 willforce it to the left until it moves into close proximity with end 180bof the vial where it engages a step 180e formed in container 180 at thejunction of the main body of the container and a reduced diameterportion 180f. During the vial filling step, air disposed within chamber180c will be expelled through a sterile vent patch 197 which is of thesame character as the previously described hydrophobic vent patch 164,which is bonded to a closure cap 198 that is provided with ventapertures 198a. Closure cap 198 functions to close the end of reduceddiameter portion 180f (FIG. 10).

After the vial has been filled with the selected fluid, cap 196 isreconnected to the container so as to maintain the interior thereof in asealed, aseptic condition. As best seen in FIG. 10, overwrap 188 isprovided with an elongated viewing slot "S" that permits viewing of theinterior chamber of the container.

As is the case with the earlier described embodiments, when thecontainer is in its sealed, sterile fluid path condition, it can bestored as may be necessary until it is to be used to fill a fluiddispenser or a reservoir of a delivery apparatus such as that shown inFIGS. 34 and 35 of U.S. Ser. No. 08/069,937.

Turning now to FIG. 15 through 19, another form of the vial assembly ofthe present invention is there shown. This embodiment is similar in manyrespects to that shown in FIGS. 5 through 9 save that the fluid chamberof the vial assembly is filled by a syringe having a blunt cannularather than a luer type connector. Like numerals have been used in FIGS.15 through 19 to identify like components.

As best seen in FIGS. 15 through 17, vial 104 has a chamber 104a withinwhich a piston-like plunger P is telescopically movable from a firstposition, proximate the fill end 104b of the vial to a second positionproximate opposite end 104c of the vial (see FIG. 17). Container 104 canbe a glass vial, or a plastic vial, or any other container suitable forthe intended end use. Container 104 has an interior wall, the interiorsurface of which can be covered by covering means such as interfacialbarrier materials or which can remain uncoated depending upon the basematerial used in constructing the container and depending upon theapplication to be made of the device.

Also forming a part of the vial assembly of this embodiment of theinvention is an outer safety casing 200, shown here as comprisingcooperating first and second portions 200a and 200b which are joinedtogether to form a sterile barrier system. First portion 200a isprovided with internal threads 202 and is closed by an externallythreaded closure cap 204. Provided at its open end is a socket likeconstruction 206 which is telescopically received within the open endportion 208 of second casing portion 200b. Outer casing 200 isreceivable over vial 104 and portions 200a and 200b are held in matingengagement by any suitable means such as bonding or by an overwrap ofthe character previously described which functions as an interfacesterility barrier and upon which appropriate identifying indicia can beimprinted (see, for example, overwrap 120). As shown in FIG. 15, a guidebead 210 is provided on portion 206. Bead 210 is receivable within acorresponding channel 212 provided in portion 200b to insure thatportions 200a and 200b are properly aligned.

In a manner presently to be described, as the fluid chamber of the vialis filled with fluid using a syringe "BC" having a blunt cannula 214(FIG. 18), plunger "P" is moved within the vial by fluid pressure fromthe first position shown in FIG. 17 to a second position shown in FIG.18 where it is disposed proximate end 104c. Plunger "P" is provided witha plurality of circumferentially extending sealing beads 215 whichsealably engage the inner walls 104d of container 104 as the pistonmoves internally thereof so as to prevent fluid leakage past the piston.

Referring now to FIGS. 17 and 18, after the vial assembly has beenassembled in the manner shown and with cap 204 removed, a slit septumclosure means 216 is exposed to view (see FIG. 18). Slit septum 216 isconstructed from any suitable elastomeric material and is provided witha slit 216a which receives blunt cannula 214 of syringe "BC". During thefilling step, septum 216 sealably closes end 104b of vial 104 andsealably engages the blunt cannula to prevent leakage between thecannula and the slit septum.

To maintain septum 216 in position within container 104, interconnectionmeans are provided which here take the form of the previously identifiedcrimp cap 150 having a skirt portion 150a, the periphery 150b of whichcan be crimped inwardly into an annular groove 152 which is provided incontainer 104 (FIG. 17). Enlarged diameter flange portion 217 of septum216 is maintained in engagement with the end of vial 104 by the crimpcap so as to sealably interconnect the septum with the vial. Crimp cap150 is also provided with a central opening 150c to receive the bluntcannula during the vial filling step.

In filling the vial assembly, cap 204 is removed and cannula 214 ofsyringe "BC" is inserted into slit septum 216 in the manner shown inFIG. 18. As fluid is forced from the syringe into a cavity 216b providedin the septum, fluid will impinge on plunger "P" forcing it to the leftuntil it moves into close proximity with end 104c of the vial where itengages a vented closure cap 220 that closes end 104c of the vial.During the vial filling step, air disposed within chamber 104a will beexpelled through a sterile vent patch 164 of the character previouslydescribed which is bonded to a closure cap 220. Cap 220 is provided withvent apertures 220a to permit free passage of gas through the apertures.

After the vial has been filled with the selected fluid, cap 204 isreconnected with the outer casing 200 so as to maintain the interior ofthe vial in a sealed, aseptic and sterile condition. In its sealed,aseptic condition, the vial assembly can be stored as may be necessaryuntil it is to be used to fill the reservoir of a platform-mounted fluiddispenser of the general character shown in FIG. 23 of U.S. Ser. No.08/129,693. The fluid dispenser, which is identified in FIG. 19 by thenumeral 225, is provided with a vial receiving opening 225a which, aftertear-away cap 220 has been removed, closely receives end portion 200b inthe manner shown in FIG. 19. Dispenser 225 includes internally disposedtabs 227 that matably engage locking tabs 201 provided in casing 200 sothat once the vial assembly is fully mated with the dispenser it cannotbe removed.

As indicated in FIG. 19, fluid dispenser 225 is provided proximateopening 225a with a blunt cannula 229 which has a fluid passageway 229a.Cannula 229 is held in position by a support member 231 so thatpassageway 229a is in communication with the fluid reservoirs of thedispenser via a fluid passageway 233. Reference should be made to Ser.No. 08/129,693 for the details of the construction of the fluiddispenser and the manner of its interconnection with cardet-like supportplatforms.

Turning now to FIGS. 20 through 23, yet another form of the vialassembly of the present invention is there shown. This embodiment issimilar in most respects to that just discussed and shown in FIGS. 15through 19 save that the telescopically movable plunger of the vialassembly is provided with outlet valve means that are operable by anoperating member provided within the platform-mountable fluid dispenser.

As best seen in FIGS. 20 and 21, vial 250 has a chamber 250a withinwhich a piston-like plunger 252, is telescopically movable from a firstposition proximate the fill end 250b of the vial to a second positionproximate opposite end 250c of the vial (see FIG. 22). As before, vial250 can be a glass vial, or a plastic vial or any other suitablecontainer.

Also forming a part of the vial assembly of this embodiment of theinvention is an outer safety casing 254, shown here as comprisingcooperating first and second portions 254a and 254b which are joinedtogether to form a sterile barrier system. First portion 254a isprovided with internal threads 256 and is closed by an externallythreaded closure cap 258. Provided at its open end is a socket-likeconstruction 260 which, as previously described, is telescopicallyreceived within the open end portion of the second casing portion. Outercasing 254 is receivable over vial 250 and portions 254a and 254b areheld in mating engagement by any suitable means such as bonding or by anoverwrap of the character previously described which functions as aninterface sterility barrier and upon which appropriate identifyingindicia can be imprinted (see, for example, overwrap 120 shown in FIG.5).

As was the case with the embodiment shown in FIGS. 15 through 19, thefluid chamber of the vial is filled with fluid using a syringe "BC"having a blunt cannula 214 (FIG. 22), plunger 252 is moved within thevial by fluid pressure from the first position shown in FIG. 21 to asecond position shown in FIG. 22 where it is disposed proximate end250c. Plunger 252 is provided with a plurality of circumferentiallyextending sealing beads 260 which sealably engage the inner walls 250dof container 250 as the piston moves internally thereof so as to preventfluid leakage past the piston.

Referring now to FIGS. 21 and 22, after the vial assembly has beenassembled in the manner shown and with cap 258 removed, a septum 262 isexposed to view. Septum 262 of the sealing means of the invention isconstructed from any suitable elastomeric material and is provided witha wall portion 262a formed of a non-coring elastomeric that includes arecess 263 which receives blunt cannula 214 of syringe "BC". During thefilling step, septum 262 sealably closes end 250b of vial 250 andsealably engages the blunt cannula to prevent leakage between thecannula and the septum.

To maintain septum 262 in position within container 250, interconnectionmeans are provided which here take the form of a crimp cap 266 having askirt portion 266a, the periphery 266b of which can be crimped inwardlyinto an annular groove 267 which is provided in container 250 (FIG. 21).Enlarged diameter flange portion 262a of septum 262 is maintained inengagement with the end of vial 250 by the crimp cap so as to sealablyinterconnect the septum with the vial. Crimp cap 266 is also providedwith a central opening 266c to receive the blunt cannula during the vialfilling step.

In filling the vial assembly, cap 258 is removed and cannula 214 ofsyringe "BC" is inserted into wall 262a in the manner shown in FIG. 22.As fluid is forced from the syringe into a cavity 268 provided in theseptum, fluid will impinge on plunger 252 forcing it to the left untilit moves into close proximity with end 250c of the vial where it engagesan elastomeric O ring which is supported by a shoulder 270 formed oncasing 254b. An elastomeric O-ring rests against shoulder 270 forengagement with the outlet end of vial 250. During the vial fillingstep, air disposed within chamber 250a will be expelled through asterile vent patch 164 of the character previously described which isbonded to an inside surface of end wall 220. Portion 254d is integrallyformed with casing 254b and includes an end wall 220 which is providedwith vent apertures 220a that permits free passage of vent gases.

After the vial has been filled with the selected fluid, cap 258 isreconnected with the outer casing 254a so as to maintain the interior ofthe vial in a sealed, aseptic and sterile condition. In its filled andsealed, aseptic condition, the vial assembly can be stored as may benecessary until it is to be used to fill the reservoir of a fluiddispenser 273 having an inlet portion as depicted in FIG. 23 and beingof the general character described in U.S. Ser. No. 08/129,693.Referring to FIG. 23, dispenser 273 is provided with a vial receivingopening 273a which closely receives end portion 254b in the manner shownin FIG. 23. Dispenser 273 includes internally disposed tabs 275 thatmatably engage locking tabs 255 provided on casing 254 so that once thevial assembly is fully mated with the dispenser it cannot be removed.

As indicated in FIGS. 23, 24, and 25, dispenser 273 is providedproximate opening 273a with valve operating means, here shown as member277, which has a fluid passageway 277a. Operating member 277 is held inposition within opening 273a so that when the vial assembly is matedwith the fluid dispenser, passageway 277a will communicate with centralfluid passageway 252a provided in plunger 252 (see FIG. 23). Passageway252a is normally closed by outlet valve means, shown here as a valvemember 280, which includes a generally disk shaped portion 280a and astem portion 280b which is generally cross-shaped in cross section (FIG.24). Portion 280a is closely receivable within a counter bore 252bprovided in plunger 252 so that when the valve means is closed as shownin FIG. 22, fluid flow between vial chamber 250a and fluid passageway252a will be substantially sealed. As indicated in FIG. 23, when thevial assembly is mated with fluid dispenser 273, portion 277b ofoperating member 277 will urge valve member 280 to the right, orinwardly of vial chamber 250a, thereby opening the valve and permittingfluid flow from chamber 250a into passageway 277a and then toward thefluid reservoirs of the fluid dispenser. Once again, reference should behad to Ser. No. 08/129,693 for the details of the construction of oneform of fluid dispenser usable with this latest embodiment of theinvention.

Referring to FIGS. 26 through 31, another form of vial assembly of thepresent invention is there illustrated and generally identified by thenumeral 300. The apparatus of this embodiment of the invention issimilar in many respects to that shown in FIGS. 15 through 19 and likenumerals are used to identify like components.

The principal difference between this latest embodiment and thoseearlier described relate to the design of the filling mechanism and thedesign of the telescopically movable plunger of the vial assembly.

As best seen in FIGS. 26 and 27, vial 104, which is of the characterpreviously described, has a chamber 104a within which a piston-likeplunger 302 is telescopically movable from a first position, proximatethe fill end 104b of the vial to a second position proximate oppositeend 104c of the vial (see FIG. 29). As before, container 104 can be aglass vial, or a plastic vial, or any other suitable container that canbe sterilized. Container 104 has an interior wall, the interior surfaceof which can be covered by covering means such as the interfacialbarrier materials previously described or the interior wall can remainuncoated depending upon the base material used in constructing thecontainer and depending upon the application to be made of the device.

Also forming apart of the vial assembly of this embodiment of theinvention is an outer safety casing 254 of the character shown in FIG.21 and as earlier described herein which functions to provide a sterilebarrier system. First portion 254a of the safety casing is provided withinternal threads 202 and is closed by an externally threaded closure cap303. As shown in FIG. 28, casing 254 is receivable over vial 104 andportions 254a and 254b are held in mating engagement by any suitablemeans such as bonding or by an overwrap of the character previouslydescribed which functions as an interface sterility barrier and uponwhich appropriate identifying indicia can be imprinted (see, forexample, overwrap 120 FIG. 5).

In a manner presently to be described, as the fluid chamber of the vialis filled with fluid using a slip fit, luer type syringe "SF", or otherappropriate filing means, plunger 302 is moved within the vial by fluidpressure from the first position shown in FIG. 28 to a second positionshown in FIG. 29 where it is disposed proximate end 104c. As before,plunger 302, which is here provided in the form of a duck-bill typevalve, has a plurality of circumferentially extending sealing beads 304which sealably engage the inner wall 104d of container 104 as the pistonmoves internally thereof so as to prevent fluid leakage past the piston.

Referring now to FIGS. 28 and 29, after the vial assembly has beenassembled in the manner shown and with cap 303 removed, the sealingmeans, including fill assembly 306, is exposed to view (see FIG. 27).Fill assembly 306, which includes the inlet valve means, comprises avalve seat member 308 having a slip-fit luer receiving nipple 310, avalve housing 312 and a valve member 314. Fill assembly 306, which alsoincludes annular seal members 316 and 317 is held in position withincasing 254a by interconnection means comprising the previouslyidentified crimp cap 150. Cap 150 includes a skirt portion 150a, theperiphery 150b of which can be crimped inwardly into an annular groove152 which is provided in container 104 (FIG. 28). Crimp cap 150 is alsoprovided with a central opening 150c to receive nipple 310 so as topermit interconnection of syringe "SF" after cap 303 has been removed.

Following interconnection of the slip-fit syringe with nipple 310 in themanner shown in FIG. 29, fluid can be forced from the syringe into acentral fluid passageway 318 provided in nipple 310. Fluid flowingthrough passageway 318 under pressure will cause valve member 314 tomove away from valve seat 308a and into engagement with the inboardportion 312a of valve housing 312 (FIG. 29). This permits fluid to flowinto chamber 104a of vial 104. Due to the novel construction of thevalve means, or duck-bill type plunger 302, "bill" portions 302a willremain closed and plunger 302 will move to the left toward end 104c ofthe vial where it engages shoulder 270 of casing 254 (FIG. 29). Duringthe vial filling step, air disposed within chamber 104a will be expelledthrough a sterile vent patch 164 of the character previously describedwhich is bonded to a closure cap 220. Cap 220 is provided with ventapertures 220a to permit free passage of gas.

After the vial has been filled with the selected fluid, cap 303 isreconnected with the outer casing 254 so as to maintain the interior ofthe vial in a sealed, aseptic and sterile condition. In its sealed,aseptic condition, the vial assembly can be stored as may be necessaryuntil it is to be used to fill the reservoir of a platform-mounted fluiddispenser. The fluid dispenser, which is identified in FIG. 30 by thenumeral 325, is provided with a vial receiving opening 325a whichclosely receives end portion 254b in the manner shown in FIG. 30.Dispenser 325 includes internally disposed tabs 227 that matably engagelocking tabs 255 provided on casing 254 so that once the vial assemblyis fully mated with the dispenser it cannot be removed.

As indicated in FIG. 30, fluid dispenser 325 is provided proximateopening 325a with a valve opening member 328 which has a fluidpassageway 328a. Member 328 is held in position by a support member 330so that passageway 328a is in communication with a central passageway330a provided in support 330 that is in communication with the fluidreservoirs of the dispenser. Once again, reference should be made toSer. No. 08/129,693 for the details of the construction of the fluiddispenser and the manner of its interconnection with cardet-like supportplatforms or with similar supports.

After tear-away cap 220 is removed and as the vial assembly is matedwith fluid dispenser 325 in the manner shown in FIG. 30, valve openingmember 328 will move between the "bill" portions 302a of the duck-billtype valve thereby permitting fluid to flow from chamber 104a intopassageway 328a, then into passageway 330a and finally into thereservoir of the fluid dispenser 325.

Turning now to FIGS. 32 through 33, yet another form of the vialassembly of the present invention is there shown. This embodiment whichis generally designated by the numeral 350 is similar in most respectsto the embodiment just discussed and shown in FIGS. 26 through 31, savethat the telescopically movable plunger of the vial assembly, ratherthan being a duck-bill type valve member, is provided with internaloutlet valve means that are operable by an operating member providedwithin a fluid dispenser of the character shown in FIG. 33. Like membersare used in FIGS. 32 through 40 to identify like components.

As indicated in FIGS. 32 through 36, vial assembly 350, if filled in themanner previously described, by a slip-fit syringe "SF". Because thesealing and inlet valve means of this form of the invention as well astheir method of operation is the same as previously described, thefilling step will not be further discussed at this time.

During filling, a piston-like plunger assembly 352 is telescopicallymovable from a first position, proximate the fill end 104b of the vialto a second position proximate opposite end 104c of the vial (see FIG.36). As best seen in FIGS. 37 and 38, plunger assembly 352 herecomprises an elastomeric member 354 having a central passageway 354a anda plurality of circumferentially extending sealing beads 354b whichsealably engage the inner wall 104d of vial 104. Mounted withinpassageway 354a is an outlet valve means which comprises a valve seatmember 356 having a valve seat 356a and a valve member 358 which ismovable toward and away from the valve seat in a manner presently to bedescribed. Also comprising a part of the outlet valve means is a lockingmember 360 which is disposed within passageway 354a. Member 360 has aflange portion 360a which is received within an annular groove 354cprovided member 354 (FIG. 38) and lockably engages an annularprotuberance 356b which is formed on valve seat member 356 and whichalso extends into groove 354c. A skirt like portion 356c extends fromprotuberance 356b and includes an inboard edge 356d that sealablyengages an elastomeric seal 361 carried by the fluid dispenser when thevial assembly is mated with the fluid dispenser.

After the vial has been filled with the selected fluid, cap 303 isreconnected with the outer casing 254a so as to maintain the interior ofthe vial in a sealed, aseptic condition. In its sealed, asepticcondition, the vial assembly can be stored as may be necessary until itis to be used to fill the reservoir of a fluid dispenser of the generalcharacter shown in FIG. 33. The fluid dispenser, which is identified inFIGS. 33 and 37 by the numeral 365, is provided with a vial receivingopening 365a which closely receives end portion 254b in the manner shownin FIGS. 33 and 37. As before, dispenser 365 includes internallydisposed tabs 275 that matably engage locking tabs 255 provided oncasing 254 so that once the vial assembly is fully mated with thedispenser it cannot be removed.

As indicated in FIGS. 37 through 40, dispenser 365 is provided proximateopening 365a with valve operating means, shown here as a member 367which has a fluid passageway 367a. Operating member 367 is held inposition within opening 365a so that when the vial assembly is matedwith the fluid dispenser, operating member 367 will be received withinskirt portion 356c of member 356 so that passageway 367a willcommunicate with vial chamber 104a when the outlet valve means is openedin the manner shown in FIG. 38. As indicated in FIG. 38, when the vialassembly is mated with fluid dispenser 365, operating member 367 willurge valve member 358 to the right, or inwardly toward vial chamber104a, thereby opening the valve and permitting fluid flow from chamber104a, between legs 367b provided on member 367 (FIG. 40), intopassageway 367a and then toward the fluid reservoirs of the fluiddispenser.

Turning next to FIGS. 41 through 47, yet another alternate form of vialassembly of the present invention is there illustrated and generallyidentified by the numeral 400. The apparatus of this embodiment of theinvention is similar in many respects to that shown in FIGS. 35, 36, and37, but includes fluid inlet and outlet valve means of a slightlydifferent construction. As before, the vial assembly includes a vial 104having a fluid chamber 104a for containing the fluid to be added to thereservoir of a fluid dispenser or other fluid delivery device.Surrounding vial 104 is an outer casing 402 having end portions 402a and402b. Because of the similarly of this embodiment to those previouslydescribed, like numerals are used where appropriate to identify likecomponents.

As was the case with the embodiment of the invention shown in FIGS. 5through 9, the fluid chamber of the vial is filled with fluid using aneedleless syringe "NS" having a conventional luer connector. In amanner presently to be described, as the fluid chamber is filled, aplunger assembly 404 is moved from the position shown in FIG. 42 towardthe position shown in FIG. 43.

Plunger assembly 404 here comprises an elastomeric member 406 having acentral passageway 406a and a plurality of circumferentially extendingsealing beads 406b which sealably engage the inner wall 104d of vial104. Mounted within passageway 406a is an outlet valve means whichcomprises a valve seat member 408 having a valve seat 408a and a valvemember 410 which is movable toward and away from the valve seat in amanner presently to be described. Also comprising a part of the outletvalve means is a locking member 412 which is disposed within passageway406a. Member 412 has a flange portion 412a which is received within anannular groove 406c provided in member 406 (FIG. 46) and lockablyengages an annular protuberance 408b which is formed on valve seatmember 408 and which also extends into groove 406c. A skirt like portion408c extends from protuberance 408b and includes an inboard edge 408dthat sealably engages an elastomeric seal 415 carried by the fluiddispenser when the vial assembly is mated with the fluid dispenser in amanner presently to be described.

For filling the fluid chamber of the vial, a syringe connector means isprovided in the form of a connector stem 418 that includes a luer typeconnector "L" which is lockably received within the syringe receptaclein the manner shown in FIG. 43. Connector stem 418 comprises a part ofthe sealing means of this embodiment of the invention which assemblyincludes inlet or fill valve means, including a valve housing 421, aswell as annular seal members 422 and 424 all of which are held inposition within casing 402 by interconnection means comprising thepreviously identified crimp cap 150.

The sealing means of this latest form of the invention includes an inletvalve means which comprises a valve seat member 428, the forward portionof which includes the previously identified connector stem 418. Therearward portion of member 428 includes a disk-like protuberance 428aand a skirt portion 428b that extends therefrom. Disposed interiorly ofskirt portion 428b is a valve seat 428c.

A cylindrical valve member 430, which also forms a part of the fillvalve means, is movable within skirt portion 428b from a closed positionwherein it sealably engages seat 428c to a valve open position shown inFIG. 43.

Following interconnection of syringe "NS" with connector 418 in themanner shown in FIG. 43, fluid can be forced from the syringe into acentral fluid passageway 418a provided in connector 418. Fluid flowingthrough passageway 418a under pressure will cause valve member 430 tomove away from valve seat 428c and into engagement with the inboardportion of member 428. When the vial is filled, valve member 430 willreturn to its closed position shown in FIG. 45.

After the vial has been filled with the selected fluid, cap 425 ispivoted downwardly relative to the outer casing and into a closedsnapped position so as to maintain the interior of the vial in a sealed,aseptic and sterile condition. In its sealed, condition, the vialassembly can be stored as may be necessary until it is to be used tofill the reservoir of a fluid dispenser. A typical fluid dispenser, isshown in FIG. 45 and identified by the numeral 435. Dispenser 435 isprovided with a vial receiving opening 435a which closely receives endportion 402b in the manner shown in FIG. 45. As before, dispenser 435includes internally disposed tabs that matably engage locking tabsprovided on casing 402 so that once the vial assembly is fully matedwith the dispenser it cannot be removed.

As indicated in FIGS. 45 and 47, fluid dispenser 435 is providedproximate opening 435a with a valve opening member 437 which has a fluidpassageway 437a. Member 437 is held in position by a support member 439so that passageway 437a is in communication with a central passageway409 defined by the interior wall of skirt portion 408c. Passageway 437ais, in turn, in communication with the fluid reservoirs of thedispenser.

When the vial assembly is mated with fluid dispenser 435, operatingmember 437 will urge cylindrical valve member 410 to the right, orinwardly toward vial chamber 104a, thereby opening the valve andpermitting fluid flow from chamber 104a, between legs 437b provided onmember 437 (FIG. 47), into passageway 437a and into the fluid reservoirsof dispenser 435.

FIGS. 48 through 51, illustrate alternate form of vial assembly of thepresent invention. The apparatus of this embodiment of the invention,which is generally designated by the numeral 450, is similar in manyrespects to that shown in FIGS. 41 through 47 except that fluid inletand outlet valve means are of a slightly different construction. Asbefore, the vial assembly includes a vial 104 having a fluid chamber104a for containing the fluid to be added to the reservoir of a fluiddispenser or other fluid delivery device. Surrounding vial 104 is anouter casing 452 having end portions 452a and 452b. Because of thesimilarly of this embodiment to the embodiment just described, likenumerals are used where appropriate to identify like components.

As best seen in FIG. 49, the fluid chamber of the vial of this latestembodiment of the invention is filled with fluid using a needlelesssyringe "S-1" having a tip 454 that is closely received within thesyringe connector portion 456 of inlet fill valve assembly 458. In amanner presently to be described, as the fluid chamber is filled, aplunger assembly 460 is moved from the position shown in FIG. 48 to theposition shown in FIG. 49 where it abuts a shoulder 462 formed on casing452.

Plunger assembly 460 here comprises an elastomeric member 464 having acentral passageway 464a and a plurality of circumferentially extendingsealing beads 464b which sealably engage the inner wall 104d of vial104. Mounted within passageway 464a is an outlet valve means whichcomprises a valve seat member 466 having a valve seat 466a and aball-type valve member 468 which is movable toward and away from thevalve seat in a manner presently to be described. Also comprising a partof the outlet valve means is a locking member 470 which is disposedwithin passageway 464a. Member 470 has a flange portion 470a which isreceived within an annular groove 464c provided member 460 (FIG. 48) andlockably engages an annular protuberance 466b which is formed on valveseat member 466 and which also extends into groove 464c. A skirt likeportion 466c extends from protuberance 466b and an includes inboard edge466d that sealably engages an elastomeric seal 472 carried by the fluiddispenser when the vial assembly is mated with the fluid dispenser in amanner presently to be described.

For filling the fluid chamber of the vial assembly, a syringe connectormeans is provided which includes the previously identified syringeconnector portions 456 within which tip 454 of the syringe istelescopically received in the manner shown in FIG. 49. Connectorportion 456 also comprises a part of the fill assembly 458 of thisembodiment of the invention, which assembly further includes the inletor fill valve means including a valve housing 477, as well as annularseal members 478 and 480 all of which are held in position within casing452 by interconnection means comprising the previously identified crimpcap 150.

The fill valve means of this latest form of the invention includes avalve seat member 484, the forward portion of which comprises thepreviously identified syringe connector portion 456. The rearwardportion of member 484 includes a disk-like protuberance 484a and a skirtportion 484b that extends therefrom. Disposed interiorly of skirtportion 484b is a valve seat 484c.

A ball-type valve member 488, which also forms a part of the fill valvemeans, is movable within skirt portion 484b from a closed positionwherein it sealably engages seat 484c to a valve open position shown inFIG. 48. Biasing means, here shown as a coil spring 490, continuouslyurges valve member 488 toward seat 484c. Valve seat member 484 can beconstructed from any suitable plastic material such as polypropylene,polystyrene, or various types of acrylics. Valve member 488 can beconstructed of similar plastic materials or can be constructed of metal,glass or various elastomers. Coil spring 480 can be constructed fromappropriate metals or plastics.

Following interconnection syringe "S-1" with connector 456 in the mannershown in FIG. 49, fluid can be forced from the syringe into a centralfluid passageway 456a provided in connector 456. Fluid flowing throughpassageway 456a under pressure will cause valve member 488 to move awayfrom valve seat 484c against the urging of spring 490. When the vial isfilled, spring 490 will urge valve member 488 to return to its closedsubstantially sealed position shown in FIG. 48.

After the vial has been filled with the selected fluid, cap 482 istheadably reconnected to the outer casing so as to maintain the interiorof the vial in a sealed, aseptic condition. In its sealed, condition,the vial assembly can be stored as may be necessary until it is to beused to fill the reservoir of a selected fluid dispenser. The fluiddispenser, which is identified in FIG. 50 by the numeral 493, isprovided with a vial receiving opening 493a which closely receives endportion 452b in the manner shown in FIG. 50. As before, dispenser 493includes internally disposed tabs that matably engage locking tabsprovided on casing 452 so that once the vial assembly is fully matedwith the dispenser it cannot be removed.

As indicated in FIGS. 50 and 52, fluid dispenser 493 is providedproximate opening 493a with a valve opening member 495 which has a fluidpassageway 495a. Member 495, which forms a part of a support member 496,is aligned with a central passageway 497 defined by the interior wall ofskirt portion 466c.

When the vial assembly is mated with fluid dispenser 493 in the mannershown in FIG. 51, operating member 495 will enter passageway 497 andurge valve member 468 to the right, or inwardly toward vial chamber 104aagainst the urging of a biasing means or spring 498, thereby opening thevalve and permitting fluid flow from chamber 104a, between legs 495bprovided on member 495 (FIG. 52), into passageway 495a and into thefluid reservoirs of dispenser 493.

Turning next to FIGS. 53 through 57, still another alternate form ofvial assembly of the present invention is there illustrated andgenerally identified by the numeral 500. The apparatus of thisembodiment of the invention is similar in many respects to that shown inFIGS. 41 through 47, but includes fluid outlet valve means of a slightlydifferent construction. As before, the vial assembly includes a vial 104having a fluid chamber 104a for containing the fluid to be added to thereservoir of a fluid dispenser or other fluid delivery device.Surrounding vial 104 is an outer casing 402 having end portions 402a and402b. Casing 402 is identical to that previously described save that end402b is provided with threads 501, the purpose of this will later bedescribed. Because of the similarly of this embodiment to thosepreviously described, like numerals are used where appropriate toidentify like components.

As was the case with the embodiment of the invention shown in FIGS. 41through 47, the fluid chamber of the vial is filled with fluid using aneedleless syringe "NS" having a conventional luer connector. In amanner presently to be described, as the fluid chamber is filled, aplunger assembly 504 is moved from the position shown in FIG. 54 towardthe position shown in FIG. 55.

Plunger assembly 504 here comprises an elastomeric member 506 having acentral passageway 506a, including an enlarged diameter portion 507, anda plurality of circumferentially extending sealing beads 506b whichsealably engage the inner wall 104d of vial 104. Mounted withinpassageways 506a and 507 is an outlet valve means which here comprisesan elastomeric valve member 508 having a peripheral bead 508a. In amanner presently to be described, valve member 508 is movable toward andaway from a porous polymer housing 510 that is disposed within anenlarged diameter portion 507. Housing 510 includes a central cavity510a which has the configuration of valve member 508 and is adapted toclosely receive the valve member.

For filling the fluid chamber of the vial, a syringe connector means isprovided in the form of a connector stem 418 that includes a luer typeconnector which is lockably received within the syringe receptacle inthe manner shown in FIG. 43. Connector stem 418 comprises a part of thefill assembly 420 of this embodiment of the invention which assembly isidentical to that shown in FIGS. 41 through 47 as previously describedherein.

Following interconnection of syringe "NS" with connector 418 in themanner shown in FIG. 55, fluid can be forced from the syringe into acentral fluid passageway 418a provided in connector 418. Fluid flowingthrough passageway 418a under pressure will cause valve member 430 tomove away from valve seat 428c and into engagement with the inboardportion of member 428. When the vial is filled, valve member 430 willreturn to its closed position as shown in FIG. 56.

After the vial has been filled with the selected fluid, cap 425 ispivoted downwardly relative to the outer casing and into a lockedposition so as to maintain the interior of the vial in a sealed, asepticcondition. In its sealed, condition, the vial assembly can be stored asmay be necessary until it is to be used to fill the reservoir of a fluiddispenser. The fluid dispenser, which is identified in FIG. 56 by thenumeral 515, is provided with an internally threaded vial receivingopening 515a which closely receives threaded end portion 402b in themanner shown in FIG. 57. As previously mentioned, casing 402b includesexternal threads 501 that threadably engage internal threads 517provided in vial receiving opening 515a of dispenser 515. Locking tabs"T" provided on casing 402 lockably engage tabs "T-1" provided ondispenser 515 (FIG. 56).

As indicated in FIGS. 57 and 58, fluid dispenser 515 is providedproximate opening 515a with a valve opening member 519 which has a fluidpassageway 521. Member 519 includes a valve member engaging element 523that engages valve member 508 and urges it into cavity 510a provided inporous member 510 when the vial assembly is mated with the fluiddispenser in the manner shown in FIG. 57. Upon valve member 508 seatingwithin cavity 510a fluid will flow from chamber 104a, through porousmember 510 into passageway 521 and then into the fluid reservoirs ofdispenser 515. (See the flow arrows of FIG. 57.)

Having now described the invention in detail in accordance with therequirements of the patent statutes, those skilled in this art will haveno difficulty in making changes and modifications in the individualparts or their relative assembly in order to meet specific requirementsor conditions. Such changes and modifications may be made withoutdeparting from the scope and spirit of the invention, as set forth inthe following claims.

I claim:
 1. An apparatus for use in infusing fluids into an ambulatorypatient at a controlled rate comprising:(a) a base assembly, including abase having a fluid inlet and fluid outlet interconnected by a fluidflow path; (b) a distendable membrane constructed of an elastic materialwhich is fitted over said base to define a reservoir in communicationwith said fluid inlet and said fluid outlet, said membrane beingdistendable by fluid introduced into said reservoir under pressurethrough said fluid inlet, said membrane having a tendency to return to asubstantially nondistended configuration whereby fluid within saidreservoir will be expelled through said fluid outlet; and (c) a fluidcontainer assembly interconnected with said base assembly said containerassembly comprising:(i) a container having a fluid chamber having aninlet and an outlet; (ii) a plunger telescopically movable within saidfluid chamber of said container as a result of fluid pressure beingexerted thereon by fluid introduced through said inlet; and (iii) inletvalve means disposed between said plunger and said inlet for controllingfluid flow into said chamber.
 2. An apparatus as defined in claim 1 inwhich said inlet valve means comprises a valve member movable inresponse to fluid pressure from a first valve closed position to asecond valve open position.
 3. An apparatus as defined in claim 1 inwhich said plunger includes a frangible portion pierceable by a cannula.4. An apparatus as defined in claim 1 further including outlet valvemeans for controlling fluid flow through said outlet of said fluidchamber.
 5. An apparatus as defined in claim 4 in which said outletvalve means comprises a valve carried by said plunger.
 6. An apparatusfor use in infusing fluids into an ambulatory patient at a controlledrate comprising:(a) a base assembly, including a base having a fluidinlet and fluid outlet interconnected by a fluid flow path; (b) adistendable membrane constructed of an elastic material which is fittingover said base to define a reservoir in communication with said fluidinlet and said fluid outlet, said membrane being distendable by fluidintroduced into said reservoir under pressure through said fluid inlet,said membrane having a tendency to return to a substantiallynondistended configuration whereby fluid within said reservoir will beexpelled through said fluid outlet; and (c) a fluid container assemblyinterconnected with said base assembly said container assemblycomprising:(i) a container including a fluid chamber having an innersurface and an inlet and an outlet; (ii) covering means for coveringsaid inner surface; and (iii) a plunger telescopically movable withinsaid fluid chamber of said container as a result of fluid pressure beingexerted thereon by fluid introduced through said inlet.
 7. An apparatusas defined in claim 6 in which said container assembly further includesinlet valve means disposed between said plunger and said inlet forcontrolling fluid flow into said chamber.
 8. An apparatus as defined inclaim 6 in which said container assembly includes outlet valve means forcontrolling fluid flow through said outlet of said fluid chamber.
 9. Anapparatus as defined in claim 6 in which said covering means comprises athin laminate interfacial structure.
 10. An apparatus as defined inclaim 6 in which said covering means comprises a plasma deposited facingsurface having vapor barrier properties.
 11. An apparatus for use ininfusing fluids into an ambulatory patient at a controlled ratecomprising:(a) a base assembly, including a base having a fluid inletand fluid outlet interconnected by a fluid flow path; (b) a distendablemembrane constructed of an elastic material which is fitted over saidbase to define a reservoir in communication with said fluid inlet andsaid fluid outlet, said membrane being distendable by fluid introducedinto said reservoir under pressure through said fluid inlet, saidmembrane having a tendency to return to a substantially nondistendedconfiguration whereby fluid within said reservoir will be expelledthrough said fluid outlet; and (c) a fluid container assemblyinterconnected with said base assembly said container assemblycomprising:(i) a container including a fluid chamber having an innersurface and an inlet and an outlet; (ii) covering means for coveringsaid inner surface; (iii) a plunger telescopically movable within saidfluid chamber of said container as a result of fluid pressure beingexerted thereon by fluid introduced through said inlet; and (iv) inletvalve means disposed between said plunger and said inlet for controllingfluid flow into said chamber.
 12. An apparatus as defined in claim 11 inwhich said inlet valve means comprises a valve member movable inresponse to fluid pressure from a first valve closed position to asecond valve open position.
 13. An apparatus as defined in claim 11 inwhich said plunger includes a frangible portion pierceable by a cannula.14. An apparatus as defined in claim 11 further including outlet valvemeans for controlling fluid flow through said outlet of said fluidchamber.
 15. An apparatus as defined in claim 14 in which said outletvalve means comprises a valve carried by said plunger.
 16. An apparatusas defined in claim 11 in which said covering means covering said innersurface of said fluid chamber comprises a thin laminate interfacialstructure.
 17. An apparatus as defined in claim 11 in which saidcovering means covering said inner surface of said fluid chambercomprises a plasma deposited facing surface having vapor barrierproperties.